Drug Safety Information for CHLORAPREP (Chlorhexidine gluconate; isopropyl alcohol)

Safety-related Labeling Changes for PREVANTICS MAXI SWABSTICK (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for CHLORAPREP ONE-STEP SEPP (CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for CHLORAPREP* (Chlorhexidine gluconate; isopropyl alcohol)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CHLORAPREP
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain125
2Osteonecrosis of jaw107
3Pyrexia103
4Pneumonia98
5Diarrhoea90
6Dyspnoea87
7Anxiety86
8Fatigue81
9Hypotension75
10Anaemia75
11Injury72
12Febrile neutropenia71
13Fall71
14Back pain69
15Nausea64
16Arthralgia62
17Abdominal pain62
18Vomiting60
19Dizziness58
20Bone disorder57

* This side effect also appears in "Top 10 Side Effects of CHLORAPREP " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CHLORAPREP
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication881
2Preoperative care286
3Prophylaxis95
4Infection prophylaxis66
5Mucosal inflammation45
6Gingivitis43
7Cough40
8Dental disorder prophylaxis30
9Anaesthesia26
10Stomatitis25

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CHLORAPREP

Total Reports Filed with FDA: 14275


Number of FDA Adverse Event Reports by Patient Age for CHLORAPREP

Total Reports Filed with FDA: 14275*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Chlorhexidine gluconate; isopropyl alcohol (Prevantics swab, Chlorascrub swab, Prevantics swabstick, Chloraprep with tint, Chloraprep one-step)

Charts are based on 14275 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CHLORAPREP Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.